NASDAQ: ARAY

Automated tools designed to help clinicians identify anatomical changes during a course of treatment, evaluate whether re-planning may be clinically beneficial and adapt radiation dose to support treatment plan objectives.

Software tools designed to support efficient retreatment planning by helping clinicians evaluate prior dose information, generate new treatment plans and assess cumulative dose for patients who have previously received radiation therapy.

System architecture that accommodates third-party surface guidance interfaces to support patient positioning, monitor positioning accuracy during treatment and enable deep inspiration breath hold (“DIBH”) workflows for selected cancer treatments.

Our CyberKnife platform and helical portfolio, including Accuray Stellar, Radixact, Accuray Helix and Tomo C Systems, where available, are designed to support advanced radiation treatments such as SRS, SBRT, IMRT, IGRT and adaptive radiation therapy. These platforms are designed to support precise treatment delivery while helping clinicians manage dose to healthy tissue and organs at risk. The CyberKnife platform is also used by neurosurgeons for radiosurgery treatments involving brain and spine tumors, as well as selected neurologic and endocrine disorders, where clinically appropriate. We also provide related services, including customer support, installation, training and other professional services.

We were incorporated in California in 1990 and commenced operations in 1992. We reincorporated in Delaware in 2007. Our principal office in the United States is located in Madison, Wisconsin.

Our Strategy

Our goal is to develop equipment and technology that help clinicians deliver precise, customized radiation treatments for patients with cancerous or benign tumors, as well as selected neurologic or endocrine disorders, where clinically appropriate. We endeavor to achieve this goal by expanding the clinical and operational options available to healthcare providers and by positioning our portfolio to address a range of customer needs, clinical priorities and market access requirements. Our strategy includes continued adoption of the CyberKnife robotic platform and a differentiated helical portfolio, with Accuray Stellar positioned for adaptive radiotherapy, the Radixact System positioned as a flexible tailored solution, and Accuray Helix positioned as an entry point into the helical portfolio. Some of the key elements of our strategy include the following:

Increase physician adoption and patient awareness to drive utilization. We are continually working to increase adoption and awareness of our systems and educate clinicians and patients regarding their capabilities and clinical applications. We hold and sponsor symposia and educational meetings and support clinical studies that evaluate the use and potential benefits of our systems. We regularly meet with clinicians to discuss the versatility of our systems and how they may be used in appropriate clinical settings. We are also expanding our digital and social presence to reach and educate a broader audience of physicians and patients. To support awareness of our product offerings, we provide our customers with tools to develop marketing and educational campaigns for their communities.

Continue to expand the radiosurgery market. The CyberKnife System is a robotic radiosurgery system designed to treat tumors throughout the body. Published literature supports the use of the CyberKnife System in the treatment of various targets, including selected cancers, benign tumors and functional indications, where clinically appropriate. The CyberKnife System is used by both radiation oncologists and neurosurgeons, supporting cross-departmental utilization in hospitals and cancer centers. This multi-specialty use may help customers evaluate the clinical, operational and economic value of the platform when making capital equipment decisions. With more than 30 years of clinical experience, the CyberKnife System supports radiosurgery applications involving the head, base of skull and spine, where treatment accuracy is important due to the proximity of tumors or targets to critical structures.

Continue to innovate through clinical development and collaboration. The development and use of our products are supported by collaboration with clinicians, researchers and other partners. We seek feedback from system users to understand customer needs and to inform product development priorities. We continue to refine and upgrade our systems, including treatment delivery, imaging, motion management, treatment planning, adaptive workflow and data management capabilities. These efforts are designed to address customer needs, improve ease of use, support workflow efficiency and strengthen the differentiation of our robotic and helical platforms.

Differentiate our portfolio to address a broader range of customer needs. We are focused on positioning our radiation therapy portfolio to address the clinical, operational and economic needs of different customer segments. Within our helical portfolio, we position differentiated solutions across a range of capabilities and access points, with Accuray Stellar positioned for adaptive radiotherapy, the Radixact System positioned as a flexible tailored solution, and Accuray Helix positioned as an entry point into the helical portfolio. This portfolio approach is designed to support customer choice, expand access to helical radiation therapy and strengthen our ability to compete across diverse markets.

Expand sales in international markets. We intend to continue to increase our sales and distribution capabilities outside of the United States to address international demand for radiation therapy solutions. Outside of the United States, we currently have regional offices in Morges, Switzerland; Hong Kong, China; Shanghai, China; and Tokyo, Japan, and direct sales staff in most countries in Western Europe, Japan, India, Korea and Canada, combined with distributors in selected international markets across Europe, the Middle East, Africa, the Asia Pacific region and Latin America. We are also focused on improving commercial execution, strengthening distributor effectiveness and increasing utilization and value derived from our installed base through enhanced customer engagement, portfolio segmentation and solution offerings.

Expand services and solutions to drive recurring revenue and customer value. We are expanding our services business beyond traditional maintenance and support toward higher-value, integrated solutions. These offerings include remote diagnostics, workflow optimization, analytics and clinical support services designed to improve system uptime, reduce variability and support clinical productivity. We are also developing AI-enabled tools intended to support predictive maintenance and faster diagnostics, including AI-guided diagnostic tools designed to assist field service engineers in identifying and resolving service issues. We believe these efforts are intended to support recurring revenue opportunities, improve service efficiency and enhance customer lifetime value.

Improve operational efficiency and cost competitiveness. We are focused on transforming our operating model to improve efficiency, reduce complexity and lower our cost structure. Our initiatives include simplifying operations, improving system reliability and throughput, optimizing our supply chain and leveraging strategic partnerships and outsourcing where appropriate. These efforts are designed to reduce cost-to-serve, enhance scalability and support competitive pricing, while maintaining the quality and performance of our solutions.

Strategic partnerships and joint ventures. We intend to pursue strategic partnerships, interoperability agreements and joint ventures that we believe may allow us to complement our growth strategy, increase sales in our current markets and expand into adjacent markets, broaden our technology and intellectual property, and strengthen our relationships with customers.

In fiscal 2016, we signed an agreement with RaySearch Laboratories AB, which led to the integration of treatment planning support for the TomoTherapy, Radixact and CyberKnife Systems in the RayStation Treatment Planning System (“TPS”) as well as interface to the RayCare Oncology Information System (“OIS”). In fiscal 2017, we signed an agreement with Photo Diagnostic Systems, Incorporated to enhance image quality of our TomoTherapy System through an enhanced image reconstruction software.

In fiscal 2019, our wholly-owned subsidiary, Accuray Asia Limited (“Accuray Asia”), entered into an agreement with CNNC High Energy Equipment (Tianjin) Co., Ltd. (the “CIRC Subsidiary”), a wholly-owned subsidiary of China Isotope & Radiation Corporation, to form a joint venture, CNNC Accuray (TianJin) Medical Technology Co. Ltd. (the “JV”), to manufacture and sell radiation oncology systems in China.

In fiscal 2021, we announced a collaboration with Brainlab to enhance and expand the CyberKnife platform’s capabilities for the neuro-radiosurgery market.

In fiscal 2023, we announced a global, commercial partnership with GE Healthcare, intended to enable both companies to advance personalized cancer care and offer solutions throughout the care pathway from precision diagnostics, precision treatment planning and delivery to precision monitoring post-treatment.

In fiscal 2024, we announced a collaboration agreement with Oncopole Claudius Regaud (IUCT-Oncopole) in France, and Airbus SAS, a leader in the aerospace industry, to develop an AI-driven solution for predicting radiotherapy system performance. We also announced an agreement with TrueNorth Medical Physics LLC to provide radiation oncology departments with third-party support services that are complementary to those already supplied by us.

In fiscal 2026, we announced a 10-year strategic collaboration agreement with the University of Wisconsin School of Medicine and Public Health (UW SMPH) to advance personalized cancer treatments using Accuray’s Stellar™ adaptive radiation therapy platform. This agreement builds on longstanding shared history of partnership between Accuray and the school to develop precision radiation therapy technologies using imaging to precisely deliver dose sculpting for cancer treatments. This newest collaboration will support clinical research, education and training, and the development of adaptive therapies that help empower medical care teams to continually raise the standard in cancer care.

Our Products

Our products include robotic and helical radiation delivery systems, supported by treatment planning, imaging, motion management, adaptive workflow and data management software. The CyberKnife platform is our robotic radiation delivery platform. Our helical portfolio includes Accuray Stellar, Radixact, Accuray Helix and Tomo C Systems, where available, and is designed to provide differentiated solutions for a range of clinical, operational and market needs.

Robotic Radiation Delivery Solutions

The CyberKnife platform is a robotic radiation delivery system designed to support SRS and SBRT treatments throughout the body. The latest generation is the CyberKnife S7 System, which combines robotic treatment delivery, advanced precision, real-time motion tracking and synchronized treatment delivery. The platform is designed to treat cancerous and benign tumors throughout the body, as well as selected neurologic and endocrine disorders, where clinically appropriate. SRS and SBRT are typically performed on an outpatient basis in a limited number of treatment sessions, often one to five fractions, with treatment delivery times that may be as low as 15 minutes.

The CyberKnife S7 System is available for sale in most major markets globally. The system includes disease-specific tracking and treatment delivery solutions for brain, spine, lung and soft tissue tumors, with dedicated solutions for prostate treatments; improvements in treatment speed compared with earlier systems; additional treatment room configuration options; and expanded treatment node options designed to increase coverage and help manage dose to healthy tissue. The CyberKnife S7 System is available in multiple configurations, including fixed collimators, the Iris Variable Aperture Collimator and the InCise multi-leaf collimator (“MLC”). With the InCise MLC, the CyberKnife S7 System is designed to support treatment of larger or irregular tumors and may expand the range of cases that can be treated with the CyberKnife platform. The InCise MLC and IMRT planning tools are designed to support treatment planning for selected IMRT cases where clinically appropriate.

In addition, we offer a specific configuration for the neuro-radiosurgery space. The CyberKnife S7 F System is designed to deliver radiosurgery treatments to central nervous system tumors and lesions with sub-millimeter accuracy. It supports precise, frameless and non-invasive radiosurgery, with features for real-time correction of positional and anatomical changes and fixed collimators to shape and direct the radiation beam when treating small targets. In combination with Brainlab Elements software, the system can support target definition and treatment planning for radiosurgery treatments for selected functional neurological indications, including essential tremor, Parkinson’s disease and epilepsy, where supported by applicable product labeling and regulatory approvals. Brainlab Elements software augments the capabilities of the Accuray Precision® Treatment Planning System for contouring, fusion and correction.

Using Synchrony real-time adaptive target tracking with dynamic delivery technology and computer-controlled robotic mobility, the CyberKnife platform is designed to deliver radiation from a wide array of beam angles and to track, detect and correct for tumor and patient movement in real time during treatment. This design is intended to support delivery of high-dose radiation with sub-millimeter precision and accuracy, while helping clinicians manage dose to surrounding healthy tissue and reduce the need for invasive head or body immobilization frames.

The Accuray Precision Treatment Planning System (“TPS”) with VOLO Optimizer software on the CyberKnife S7 System is designed to improve operational efficiency by reducing both treatment planning time and treatment delivery time. The next-generation TPS with VOLO Optimizer facilitates the development of clinically acceptable treatment plans up to an estimated 90 percent faster than before and treatment delivery up to an estimated 50 percent faster than before the availability of this software.

We believe that our robotic delivery systems offer clinicians and patients the following benefits:

Robotic treatment delivery architecture. The CyberKnife platform features a compact linear accelerator mounted on a highly maneuverable robotic arm that moves around the patient while delivering isocentric or non-isocentric, non-coplanar radiation beams from a wide range of angles. This architecture is designed to tailor radiation delivery to the target while helping clinicians manage dose to healthy tissue and maintain sub-millimeter accuracy and precision, including for targets that move during treatment. We believe the CyberKnife platform is a clinical solution for cases where accuracy, flexibility, speed and patient comfort are important considerations.

Treatment of inoperable or surgically complex tumors. The CyberKnife platform may be used to target tumors that cannot be easily treated with traditional surgical techniques because of their location, number, size, shape or proximity to vital tissues or organs, or because of the age or health of the patient. The CyberKnife platform’s robotic architecture and image guidance capabilities are designed to support precise targeting while helping clinicians manage dose to surrounding healthy tissue.

Treatment of tumors throughout the body. The CyberKnife platform has been cleared by the Food and Drug Administration (“FDA”) to provide treatment planning and image-guided radiation therapy treatment for tumors anywhere in the body where radiation treatment is indicated. The CyberKnife platform is used for the treatment of primary and metastatic tumors outside the brain, including tumors on or near the spine and in the breast, kidney, liver, lung, pancreas and prostate, in addition to tumors in the brain. The platform is designed to support sub-millimeter accuracy across disease sites, where clinically appropriate.

Real-time tracking of tumor movement. The CyberKnife platform is designed to accommodate patient and tumor motion during treatment. With Synchrony real-time adaptive target tracking with dynamic delivery technology, the CyberKnife platform is designed to adapt treatment delivery for targets that move during treatment and may help clinicians reduce treatment margins and manage dose to surrounding healthy tissue.

Patient experience considerations. The CyberKnife platform is designed to support patient comfort during treatment. Patients may be treated with the CyberKnife platform on an outpatient basis without anesthesia and without the risks associated with traditional surgery. In many cases, CyberKnife System treatments require limited pretreatment preparation and may reduce or eliminate the need for invasive rigid head frames or other immobilization approaches.

Potential to support broader patient access. We believe clinical use of the CyberKnife platform may allow customers to treat selected patients and cases where high precision and the ability to account for motion are important, including patients who may not otherwise have been treated with radiation or who may not be good candidates for surgery.

Upgradeable modular design. The CyberKnife platform has a modular design that facilitates implementation of upgrades, which may allow customers to gain access to new features without purchasing an entirely new system. We continue to develop and offer clinical capabilities designed to enhance ease of use, reduce treatment times, improve accuracy and support patient access. The main components and options of the CyberKnife platform include a compact X-band linear accelerator, robotic manipulator arm and real-time image guidance system with continuous target tracking and correction.

Key features of the main components include:

Compact X-band linear accelerator. The CyberKnife S7 System utilizes a compact X-band linear accelerator (linac) mounted on a robotic manipulator arm. The side-coupled-cavity radiofrequency standing wave linac is fitted with a triode electron gun, demountable target, and demountable radiofrequency window.

Robotic manipulator arm. The robotic manipulator arm, with six-degrees-of-freedom range of movement, is designed to move around the patient to position the linac and direct the radiation with a high level of precision and repeatability. The manipulator arm provides what we believe is a differentiated method of positioning the linac to deliver doses of radiation from a broad range of directions and positions, without the limitations inherent in gantry-based systems, creating non-isocentric, non-coplanar composite dose patterns with a high level of conformance to the shape of each treated tumor. This flexibility supports diversification of beam trajectories and beam entrance and exit points, helping clinicians manage dose to healthy tissue near the tumor. Furthermore, the rapid response time of the manipulator arm allows tracking of tumors that are prone to movement.

Real-time image guidance system with continuous target tracking and correction. Synchrony real-time adaptive target tracking with dynamic delivery technology is designed to continuously monitor and correct for patient and tumor movement during treatment delivery. The system correlates low-dose, real-time treatment X-rays with images previously taken with a CT scan of the tumor and surrounding tissue to help direct radiation beams with precision using real-time feedback. This capability supports delivery of conformal, non-isocentric radiation dose to the target while helping clinicians manage dose to surrounding healthy tissue. Synchrony is designed to adapt and synchronize the treatment delivery beam position to the target location during the delivery of a treatment fraction. The beams of radiation are delivered continuously throughout the treatment session as the patient breathes naturally. We believe Synchrony supports accurate delivery for lung tumors that move with respiration without the need for implanted fiducials, and supports delivery of radiation dose with sub-millimeter precision and accuracy, including for tumors that are prone to movement.

Imaging sources. The low energy X‑ray sources generate the images that help determine the location of bony or other anatomic landmarks, or implanted fiducials, which are used for tracking throughout the entire treatment.

Imaging detectors. The image detectors capture high resolution anatomical images throughout the treatment. These live images are continually compared to the patient’s CT scan to determine real time patient positioning. Based on this information, the robotic manipulator automatically corrects for detected movements.

In addition to the main components listed above, we also offer the following components and options: Lung Optimized Treatment; Synchrony Fiducial Tracking with the InTempo Imaging System; RoboCouch Patient Positioning System; Xchange Robotic Collimator Changer; Iris Variable Aperture Collimator; and the InCise MLC. Key features of some of these components are as follows:

Synchrony Skull, Spine and Lung Tracking Systems. The Synchrony Skull, Spine and Lung Tracking Systems allow for tracking of tumors without the need for implanted markers in the skull, spine and the lung.

Lung Optimized Treatment. An integrated suite of tools designed to support fiducial-free lung tracking and non-invasive lung SBRT treatments.

InTempo Imaging System. The InTempo Imaging System with the Synchrony Fiducial Tracking System is designed to optimize imaging frequency during prostate treatments, for example, using time-based image guidance to assist with tracking and correcting non‑predictable intrafraction target motion.

Iris Variable Aperture Collimator. The Iris Variable Aperture Collimator enables delivery of beams in 12 unique sizes with a single collimator, which significantly reduces treatment times and supports efficient treatment delivery.

Fixed Collimators. The Fixed Collimators enable delivery of beams in 12 unique sizes with 12 different collimators, usually used for radiosurgery.

InCise Multileaf Collimator. The InCise MLC is designed to support precise SRS and SBRT treatments with the CyberKnife platform while significantly reducing treatment times. With the InCise MLC, the CyberKnife S7 Series can be used to treat larger and irregular tumors more efficiently.

The long-term success of the CyberKnife platform is dependent on a number of factors including the following:

Continued adoption of our CyberKnife platform, including the CyberKnife M6 System and CyberKnife S7 System, in markets where they are available;

Greater awareness among physicians and patients of the capabilities of the CyberKnife platform, including its robotic architecture, Synchrony technology and VOLO Optimizer;

Continued development of clinical studies evaluating the safety, efficacy and use of the CyberKnife platform to treat tumors in various parts of the body;

Change in medical practice leading to utilization of stereotactic body radiation therapy more regularly as an alternative to surgery or other treatments;

Continued advances in our technology that improve the quality of treatments and ease of use of the CyberKnife platform;

Receipt of regulatory approvals in various countries which are expected to improve access to radiosurgery with the CyberKnife S7 System in such countries;

Medical insurance reimbursement policies that cover CyberKnife platform treatments; and

Our ability to expand sales of CyberKnife platform configurations in countries throughout the world where we do not currently sell or have not historically sold a significant number of CyberKnife systems.

Helical Radiation Delivery Solutions

Building on the TomoTherapy platform, our helical portfolio has evolved into a differentiated set of radiation delivery systems designed to address varying customer needs, including adaptive radiotherapy, flexible tailored treatment delivery and broader access to helical radiation therapy.

Helical radiation therapy integrates linear accelerator and CT imaging technology to deliver radiation from multiple 360-degree rotations around the patient while the patient table moves through the center of the system. This design supports conformal dose delivery and helps clinicians manage dose to healthy tissue and organs at risk.

Accuray Stellar is positioned as our helical platform for adaptive radiotherapy, designed to combine helical treatment delivery, advanced imaging, treatment planning and workflow capabilities to support adaptive treatment approaches.

The Radixact System is positioned as a flexible tailored helical solution. It integrates radiation treatment planning, delivery, imaging and data management and offers TomoHelical™ and TomoDirect™ delivery modes, supporting a broad range of clinical cases from routine treatments to more complex cases.

Accuray Helix is positioned as an entry point into the helical portfolio. It is designed to combine helical delivery capabilities with automation and workflow tools for facilities seeking access to advanced radiation therapy capabilities with a more accessible system configuration.

The Tomo C System is a locally branded, made-in-China radiation therapy system developed through the CNNC-Accuray joint venture. It is intended to support access to helical radiation therapy in China, subject to applicable regulatory approvals and market availability.

We believe that our helical portfolio offers clinicians and patients the following benefits, depending on system configuration and market availability:

Versatile treatment capabilities. The ring gantry architecture enables precise and efficient treatments with a high degree of dose conformity. The high-speed binary MLC is integrated with the linac and consists of 64 individual low-leakage tungsten leaves that move across the beam to either block or allow the passage of radiation, modulating and shaping the beam as it is emitted. The combination of the ring gantry and high-speed MLC enables treatment to be delivered continuously in a 360-degree helical pattern around the patient’s body, which we refer to as TomoHelical. The TomoDirect feature provides additional versatility by enabling high-quality, fixed-angle beam delivery for cases suited to fixed-angle radiation delivery. Helical systems can support non-isocentric 3D conformal radiotherapy (“3D CRT”), IG-IMRT, or stereotactic treatments within a typical cylindrical volume of 40 centimeters in diameter and up to 135 centimeters in length. This expansive treatment field supports treatment of single or multiple tumors in a single session, where clinically appropriate.

ClearRT helical kVCT imaging technology. ClearRT helical kVCT imaging technology is available on selected helical systems and configurations. It is designed to produce high-quality CT images efficiently, with imaging field of view and imaging length capabilities that vary by system configuration. On selected Radixact and Accuray Stellar System configurations, ClearRT offers an imaging field of view of up to 50 centimeters in diameter and an imaging length of up to 135 centimeters, supporting broad anatomical visualization. The Accuray Helix System supports ClearRT Standard on selected configurations, with a more limited imaging length than the maximum ClearRT configuration available on Radixact and Accuray Stellar Systems. This imaging capability may assist clinicians in evaluating anatomical changes during the treatment course. On Radixact and Accuray Stellar Systems, ClearRT images may also be used with the Accuray PreciseART automated dose trending tool, which helps clinicians evaluate whether plan adaptation may be beneficial.

Integrated treatment system for supporting precise radiation delivery. We believe the integration of imaging, treatment planning and helical radiation delivery capabilities supports accurate and precise radiation therapy. Our planning software helps allow clinicians to define the contours of a tumor and nearby radiosensitive structures. The helical portfolio uses dose optimization algorithms designed to help shape dose to the target while helping clinicians manage dose to surrounding healthy tissue and organs at risk.

Enhancing efficiency and quality of treatment planning and delivery. We are committed to providing clinical teams with technologies that support efficient and high-quality radiation therapy planning. VOLO Ultra, our next-generation optimization engine, is designed to accelerate treatment planning while supporting plan quality, workflow efficiency and adaptive radiotherapy workflows.

Efficient clinical workflow for image-guided and adaptive radiation therapy. Helical systems integrate key radiation therapy workflow elements, including treatment planning, CT image-guided patient positioning, treatment delivery, quality assurance and adaptive planning. The integrated workflow is designed to help clinical teams scan, plan, treat and evaluate patients efficiently. Treatment plans and daily images can also be accessed remotely, supporting collaboration among clinical team members regardless of location.

Low barriers to installation and implementation. External beam radiation systems must be housed in rooms with appropriate radiation shielding. The compact and self-contained design of our helical systems may allow customers to retrofit existing treatment rooms previously used for legacy radiation therapy systems and reduce the need for construction of new, larger treatment rooms. With imaging and radiation delivery capabilities integrated on a ring gantry, our helical systems may require less space than certain other linac systems. In addition, our helical systems have an integrated radiation beam stop designed to reduce shielding requirements compared with traditional systems. We preassemble, test and commission each system at our manufacturing facility and ship systems substantially assembled, which is designed to support efficient installation and implementation.

TomoEDGE Delivery. TomoEDGE dynamically varies the width of the collimator jaws during treatment delivery to tailor the beam to the target. This feature is designed to support treatment efficiency, dose conformity and management of dose to nearby healthy tissue and organs at risk. The resulting gains in treatment quality and speed may support use of selected helical systems across conventional and stereotactic radiotherapy applications.

Platform for adaptive radiation therapy. Our helical portfolio is designed to support adaptive radiation therapy workflows through the integration of imaging, treatment planning, treatment delivery and data management capabilities. These capabilities may help clinicians evaluate anatomical changes during a course of treatment and determine whether plan adaptation may be beneficial.

In addition to the functionality listed above, selected helical systems may be enhanced with product options including Synchrony and VitalHold:

Real-time adaptive tracking of tumor movement. Synchrony real-time adaptive target tracking with dynamic delivery technology is designed to adapt treatment delivery for targets that move during treatment. On the Radixact System, Synchrony may be used for tumors that move as a result of respiration, digestion or patient movement. Synchrony is designed to synchronize the treatment beam position to the target location during the delivery of a treatment fraction, allowing beams of radiation to be delivered continuously while the patient breathes naturally. This capability may help clinicians account for target motion during treatment and manage dose to surrounding healthy tissue.

The VitalHold Solution is a connectivity license that enables selected helical systems to interface with compatible third-party surface guided radiation therapy (“SGRT”) systems. SGRT is designed to support patient positioning and monitor positioning accuracy during treatment. Availability of specific SGRT-enabled workflows, including DIBH, depends on the connected SGRT vendor, system configuration and market availability.

We believe the long-term success of our helical portfolio is dependent on a number of factors, including the following:

Continued adoption of our helical portfolio, including Accuray Stellar, Radixact, Accuray Helix and Tomo C Systems, where available;

Greater awareness among physicians and patients of the capabilities of our helical portfolio, including helical treatment delivery, ClearRT helical kVCT imaging, adaptive workflow tools and portfolio options designed to address different customer needs;

Advances in our technology that improve treatment planning, workflow efficiency, imaging, adaptive radiotherapy and ease of use of the helical portfolio;

Greater awareness among physicians of the reliability and clinical utility of our helical portfolio; and

Our ability to expand sales of helical portfolio configurations in countries throughout the world where we do not currently sell or have not historically sold a significant number of helical systems.

Our Software Solutions

Our Accuray Precision Treatment Planning System (“TPS”) and iDMS Data Management System provide integrated treatment planning and data management capabilities for use with compatible Accuray delivery platforms.

Accuray Precision Treatment Planning.

Accuray Precision TPS is designed to support efficient generation and evaluation of radiation therapy treatment plans for compatible Accuray delivery platforms. It includes capabilities such as multi-modality image fusion, deformable image registration, contouring tools, AutoSegmentation and auto-contouring options for selected anatomical sites, side-by-side treatment plan comparison, plan summation and plan evaluation. Accuray Precision TPS supports treatment plan creation using TomoHelical, TomoDirect, IMRT and 3D CRT planning modes on compatible helical systems enabled with iDMS Data Management System. It also supports treatment planning on CyberKnife platforms, including frameless intracranial radiosurgery, fiducial-free lung tracking with dynamic motion synchronization, SBRT for selected anatomical sites and IMRT. Accuray Precision TPS includes dose computation engines for compatible Accuray platforms, including Monte Carlo dose calculation for the CyberKnife InCise MLC and VOLO technology for CyberKnife and selected helical systems. The VOLO and VOLO Ultra solutions are designed to support high-speed dose calculation and optimization, helping clinicians develop customized treatment plans efficiently and interactively.

Accuray Precision TPS may be further enhanced with optional advanced capabilities, depending on system configuration and market availability, including the following:

PreciseART Adaptive Radiation Therapy Option. The PreciseART Adaptive Radiation Therapy Option is available on selected compatible helical systems, depending on system configuration and market availability. PreciseART is designed to support adaptive radiotherapy workflows by helping clinicians monitor anatomical changes during treatment and evaluate whether plan adaptation may be beneficial. The software provides automated processing of daily imaging and enables clinical teams to set protocol-specific action levels to flag cases for review. Its re-planning workflow leverages integration of treatment delivery, treatment planning and data management systems to help clinicians generate new treatment plans based on prior plan data. PreciseART is designed to support review of tumor coverage and organs-at-risk dose when evaluating plan adaptation.

PreciseRTX Retreatment Option. The PreciseRTX Retreatment Option is designed to support retreatment planning by helping clinicians evaluate prior dose information, generate new treatment plans and assess cumulative dose for patients who have previously received radiation therapy. The workflow includes importation of patient dose data from Accuray or non-Accuray planning systems, deformation of original plan contours onto a new treatment planning CT, deformation of previously delivered dose onto a new planning CT, generation of a retreatment plan based on information from the existing plan, and summation of the original and new treatment plans to review cumulative dose.

Accuray iDMS Data Management System. Accuray iDMS provides a centralized platform for storing and managing patient treatment plan data for compatible Accuray platforms. Designed to integrate with a range of technologies and systems, iDMS enables users and applications to access data needed to support treatment workflows. Information for patients treated on iDMS-compatible Accuray platforms can be maintained as a single treatment record, providing flexibility to treat patients on compatible Accuray platforms. iDMS supports user and privilege management to control patient data access. It also supports the Storage Vault option, which is designed to maintain encrypted patient data, and customizable reporting through the Report Administration application. In addition, iDMS enables connectivity between Accuray platforms and other systems in radiation oncology departments across the radiotherapy workflow. iDMS offers several key capabilities:

OIS Connect Option. The OIS Connect software option is a Digital Imaging and Communications in Medicine (“DICOM”) standard-based solution designed to interface iDMS-enabled Accuray platforms with compatible OISs. This integration with electronic medical record systems supports export of radiotherapy treatment history delivered using compatible Accuray platforms.

Total Quality Assurance (TQA™) package. The TQA application offers trending and reporting of system and dosimetric parameters designed to support monitoring of selected helical system performance.

Delivery Analysis™. Delivery Analysis is an option for selected helical systems designed to support pretreatment quality assurance and treatment delivery review. The software can use detector signals to support evaluation of delivered dose during a patient’s treatment course. Delivery Analysis provides summary-level analytics and detailed analysis capabilities.

Sales and Marketing

In the United States, we primarily market directly to customers, including hospitals and stand-alone treatment facilities, through our sales organization, and we also market to customers through sales agents and group purchasing organizations. Outside the United States, we market to customers directly and through distributors and sales agents. We currently have international offices in Morges, Switzerland; Hong Kong, China; Shanghai, China; and Tokyo, Japan, and direct sales staff in most countries in Western Europe, Japan, India, Korea and Canada. In addition, we have distributors in selected international markets across Europe, including Russia where permitted by applicable laws and regulations, the Middle East, Africa, the Asia Pacific region and Latin America.

Our commercial approach is designed to position our portfolio according to customer needs, clinical priorities, market access requirements and available infrastructure. Within the helical portfolio, we position Accuray Stellar for customers seeking adaptive radiotherapy capabilities, the Radixact System for customers seeking a flexible tailored helical solution, and the Accuray Helix System as an entry point into the helical portfolio. This segmentation supports more targeted customer engagement across direct and distributor-led markets.

In direct sales markets, we employ a combination of territory sales managers, product specialists, training specialists and marketing managers. Territory sales managers and product specialists are responsible for selling the systems to hospitals and stand‑alone treatment facilities. Our marketing managers help market our current products and work with our engineering group to identify and develop upgrades and enhancements for our suite of products. Our training specialists train radiation oncologists, surgeons, physicists, dosimetrists and radiation therapists.

We market our products to radiation oncologists, neurosurgeons, general surgeons, oncology specialists and other referring physicians in hospitals and stand-alone treatment facilities. We intend to continue to increase our focus on marketing and education efforts directed to surgical specialists and oncologists responsible for treating tumors throughout the body. We also work with hospital administrators to discuss clinical, operational and economic considerations associated with our offering. Our marketing activities include efforts to provide educational information to patients regarding treatment options involving the CyberKnife platform and our helical portfolio, where appropriate.

Under our standard distribution agreement, we generally appoint a distributor for a specific country. We typically also retain the right to distribute our full portfolio of solutions in such territories. In most territories, our distributors generally provide the full range of service and sales capabilities, although we may provide installation and service support for certain distributors.

The JV aims to be uniquely positioned to serve China, which we believe is the world’s largest growth market for radiation oncology systems. China represents a significantly underserved market for linacs based on the country’s population and cancer incidence rates on both an absolute and relative country basis. Accuray Asia has a 49% ownership interest in the JV, and the CIRC Subsidiary has a 51% ownership interest in the JV.

We also face competition in China from multinational and domestic manufacturers, including companies developing locally manufactured radiation therapy and radiosurgery systems.

With the receipt of the necessary permits and licenses to operate, the JV has been selling products in China, much like a distributor since 2019. The JV has been manufacturing and selling a locally branded “Made in China” radiotherapy device, or the Tomo® C radiation therapy system, in the Class B license category since fiscal year 2024. We believe this strategy will allow us to best maximize both near and longer-term opportunities in China. In September 2023, we received approval for our Class B device from the National Medical Products Administration (“NMPA”), and our Accuray Precision Treatment Planning System for the Class B device was approved by the NMPA in June 2024. The JV also distributes other Accuray treatment delivery systems like the Radixact and CyberKnife treatment delivery systems, including the Radixact SynC and CyberKnife S7 Systems, which received NMPA approval in January 2025.

For more information on the JV, see Note 11, “Joint Venture,” of the Notes to the consolidated financial statements.

Manufacturing

We purchase major components for each of our products from outside suppliers, including the robotic manipulator, treatment couches, gantry, magnetrons and computers. We closely monitor supplier quality, delivery performance and conformance to product specifications, and we also expect suppliers to contribute to our efforts to improve our manufacturing cost and quality.

Some of the components are obtained from single‑source suppliers. These components include the couch, magnetron and solid state modulator for the TomoTherapy platform and the robot, couch, and magnetron for the CyberKnife platform. In most cases, if a supplier was unable to deliver these components, we believe we would be able to find other sources for these components subject to any regulatory qualifications, if required. In the event of a disruption in any of these suppliers’ ability to deliver a component, we would need to secure a replacement supplier. Additionally, any disruption or interruption of the supply of key subsystems could result in increased costs and delays in deliveries of our treatment systems, which could adversely affect our reputation and results of operations. To help mitigate these risks, we negotiate long‑term supply contracts or submit long‑term orders and forecasts to our single‑source suppliers with the goal that our demand can be satisfied and any capacity problem can be mitigated.

Currently, we manufacture our CyberKnife and TomoTherapy platforms in Madison, Wisconsin. We manufacture the linear accelerator for our CyberKnife and TomoTherapy platforms at our Chengdu, China facility. Our facilities employ state‑of‑the‑art manufacturing techniques and equipment. Our Madison headquarters manages and oversees the complete design, manufacturing, installation, service and distribution for our medical devices under one global quality management systems compliant to the internationally recognized quality system standard for medical devices ISO, 13485:2016, and the Quality System regulations enforced by the FDA. We believe our manufacturing facilities will be adequate for our expected growth and foreseeable future demands for at least the next three years.

The manufacturing processes at our facilities include fabrication, subassembly, assembly, system integration and final testing. Our manufacturing personnel consist of fabricators, assemblers and technicians supported by production engineers as well as planning and supply chain managers. Our quality assurance program includes various quality control measures from inspection of raw material, purchased parts and assemblies through on‑line inspection. We have also incorporated lean manufacturing techniques to improve manufacturing flow and efficiency. Lean manufacturing techniques include reducing wasteful and extraneous activities, balancing assembly and test flow, as well as better utilizing production assets and resources.

Intellectual Property

The proprietary nature of, and protection for, our products, product components, processes and know‑how are important to our business. We seek patent protection in the United States and internationally for our systems and other technology where available and when appropriate. We may also in‑license the technology, inventions and improvements that we consider important to the development of our business. In addition, we also rely upon trade secrets, know‑how, trademarks, copyright protection, as well as confidentiality agreements with employees, consultants and other third parties, to protect our proprietary rights and to develop and maintain our competitive position.

As of June 30, 2026, we held an exclusive field of use licenses or ownership of 623 U.S. and foreign patents, and 52 U.S. and foreign patent applications. These patents and applications cover various components and techniques incorporated into the CyberKnife and TomoTherapy platforms, or which may be incorporated into new technologies under current development, all of which we believe will allow us to maintain a competitive advantage in the field of radiation therapy systems. We cannot be certain that any patents will be issued from any of our pending patent applications, nor can we be certain that any of our existing patents or any patents that may be granted to us in the future will provide us with protection.

We periodically monitor the activities of our competitors and other third parties with respect to their use of intellectual property.

Research and Development

Continued innovation is critical to our future success. Our current product development activities include projects expanding clinical applications, driving product differentiation, and continually improving the usability, interoperability, reliability, and performance of our products. We continue to seek to develop innovative technologies so that we can improve our products and increase our sales. Some of our product improvements have been discussed above under the heading “Our Products.”

Our research activities strive to enable new product development opportunities by developing new technologies and advancing areas of existing core technology such as next generation linear accelerators, adaptive therapy, patient imaging, motion management, or treatment planning capabilities.

The modular design of our systems support rapid development for new clinical capabilities and performance enhancements by generally allowing each subsystem to evolve within the overall platform design. Access to regular product upgrades protects customer investment in the system, facilitates the rapid adoption of new features and capabilities among existing installed base customers, and drives increasing value in our multiyear service plans. These upgrades will generally consist of software and hardware enhancements designed to increase the ease of use of our systems, improve the speed and accuracy of patient treatment and meet other customer needs.

A key component of our research and development program is our collaboration with research programs at selected hospitals, cancer treatment centers, academic institutions and research institutions worldwide. Our agreements with these third‑party collaborators generally require us to make milestone‑based payments during the course of a particular project and often also require that we make up‑front payments to fund initial activities. Generally, we obtain non‑exclusive worldwide rights to commercialize results from the collaboration with an option to negotiate an exclusive license. For inventions resulting from the collaboration that we own or exclusively license, we generally grant a royalty‑free license for the purpose of continuing the institution’s research and development, and from time to time, we also grant broader licenses. Our research collaboration programs include work on clinical protocols and hardware and software developments. We also work with suppliers to develop new components in order to increase the reliability and performance of our products and seek opportunities to acquire or invest in the research of other parties where we believe it is likely to benefit our existing or future products.

We have entered into collaboration agreements with a variety of industrial partners within the fields of radiation oncology and medical imaging to provide us with opportunities to accelerate our innovation capability and bring complementary products and technologies to market. We continue to seek out new partnerships to complement our internal developments and implement our product strategies.

Competition

The medical device industry in general and the non‑invasive cancer treatment field in particular, are subject to intense and increasing competition and rapidly evolving technologies. Because our products often have long development and regulatory approval cycles, we must anticipate changes in the marketplace and the direction of technological innovation and customer demands. To compete successfully, we will need to continue to demonstrate the advantages of our products and technologies over well established alternative procedures, products and technologies, and convince physicians and other healthcare decision makers of the advantages of our products and technologies. Traditional surgery and other forms of minimally invasive procedures, brachytherapy, chemotherapy, immunotherapy, and other drugs remain alternatives or are complementary to treatments delivered with the CyberKnife and TomoTherapy platforms.

New product sales in this competitive market are primarily dominated by two companies: Varian Medical Systems, Inc, a Siemens Healthineers company (“Varian”) and Elekta AB (“Elekta”). Some manufacturers of standard linac systems, including Varian and Elekta, have products that can be used in combination with body and/or head frame systems and image guidance-systems to perform both radiosurgical and radiotherapy procedures. Our other competitors include RefleXion Medical Inc., ZAP® Surgical Systems, Inc., United Imaging Healthcare Co., Ltd., and other companies in the radiosurgical and radiation therapy markets.

Furthermore, many government, academic and business entities are investing substantial resources in research and development of cancer treatments, including surgical approaches, radiation treatment, MRI-guided radiotherapy systems, proton therapy systems, drug treatment, immunotherapy, gene therapy, and other approaches. Successful developments that result in new approaches for the treatment of cancer could reduce the attractiveness of our products or render them obsolete.

Our future success will depend in large part on our ability to establish and maintain a competitive position in current and future technologies. Rapid technological development may render the CyberKnife and helical platforms and their technologies obsolete. Some of our competitors have or may have greater corporate, financial, operational, sales and marketing resources, and more experience in research and development than we have. We cannot assume that our competitors will not succeed in developing or marketing technologies or products that are more effective or commercially attractive than our products or that would render our technologies and products obsolete or less useful. We may not have the financial resources, technical expertise, marketing, distribution or support capabilities to compete successfully in the future.

Our competitive position also depends, among other things, on:

Widespread awareness, acceptance and adoption of our products by the radiation oncology, cancer therapy and neurosurgery markets;

Innovations that improve the effectiveness and productivity of our systems’ treatment processes and enable them to address emerging customer needs;

Availability of reimbursement coverage from third-party payors (including insurance companies, governments, and/or others) for procedures performed using our platforms;

Inclusion of radiotherapy in countries’ cancer treatment policies as an effective treatment modality;

Published, peer-reviewed data supporting the efficiency, efficacy and safety of our platforms;

Limiting the time required from proof of feasibility to routine production;

Limiting the time period and cost of regulatory approvals or clearances;

The manufacture and delivery of our products in sufficient volumes on time, and accurately predicting and controlling costs associated with manufacturing, installation, warranty and maintenance of the products;

Our ability to attract and retain qualified personnel;

The extent of our intellectual property protection or our ability to otherwise develop and safeguard proprietary products and processes;

Our ability to successfully expand into new and developing markets;

Securing sufficient capital resources to expand both our continued research and development, and sales and marketing efforts; and

Obtaining and maintaining any necessary United States or foreign regulatory approvals or clearances.

Our customers’ equipment purchase considerations typically include reliability, treatment quality, service capabilities, patient throughput, price, payment terms and equipment supplier viability. We believe we compete effectively on price and overall value based on our platforms’ technological capabilities. We continue to focus on providing advanced products designed to deliver precise radiation treatments and reliable clinical outcomes in line with customer expectations.

In addition to competition from technologies performing similar functions as our platforms, competition also exists for the limited capital expenditure budgets of our customers. For example, our platforms may compete with other equipment required by a radiation therapy department for financing under the same capital expenditure budget, which is typically limited. A purchaser, such as a hospital or cancer treatment center, may be required to select between the two items of capital equipment. Our ability to compete may also be adversely affected when purchase decisions are based solely upon price, since our products are premium priced systems due to their higher level of functionality and performance.

U.S. Reimbursement

In the United States, healthcare providers that purchase capital equipment such as the CyberKnife and/or TomoTherapy platforms generally rely on government and private third-party payors for reimbursement for the healthcare treatment and services they provide. Examples of these types of payors include Medicare, Medicaid, private health insurance plans, and health maintenance organizations, which reimburse all or a portion of the cost of treatment, as well as related healthcare services. Reimbursement involves three components: coverage, coding and payment.

Coverage

There are currently no National Coverage Determinations in place under Medicare for treatments provided on a CyberKnife, TomoTherapy, or Radixact platform. Medicare coverage criteria for treatments performed on a CyberKnife, TomoTherapy, or Radixact platform is outlined in Local Coverage Determinations or, in the absence of a formal policy, treatment is covered as long as it is considered reasonable and necessary. The most common indications covered by Medicare in Local Coverage Determinations for radiotherapy are primary and metastatic tumors in the brain, spine, lung, liver, kidney, pancreas, adrenal gland, head and neck, breast, prostate, abdominal and retroperitoneal regions, as well as other cancers that have failed previous treatment. Commercial payor policies vary with respect to coverage for radiotherapy including many of the indications covered by Medicare, though coverage criteria may differ.

Coding

Radiosurgery treatment delivery in the hospital outpatient department is billed under CPT codes 77371 and 77372 for single fraction intracranial radiosurgery and CPT code 77373 for extracranial/multi-session radiosurgery/SBRT. In freestanding centers, robotic radiosurgery is billed under HCPCS codes G0339 and G0340, and the non-robotic SRS/SBRT codes (77371–77373) are also payable in that setting.

CMS has consolidated radiation treatment delivery coding into a single technique-agnostic structure. CPT codes 77385 and 77386, previously used to bill IMRT delivery, have been deleted; IMRT is no longer billed separately from other external beam techniques. Instead, delivery is reported under three complexity-based tiers — CPT codes 77402 (Level 1), 77407 (Level 2), and 77412 (Level 3) — based on factors such as the number of treatment sites/isocenters and use of active motion management, rather than on whether the treatment is 3D-CRT, IMRT, or another technique. Treatments delivered using the TomoTherapy and Radixact Systems are therefore coded based on delivery complexity rather than modality.

We expect all valid delivery codes to be recognized by commercial payers, though adoption of the revised codes across commercial and state Medicaid payers has not been uniform, which has led some practices to experience claim processing delays. Other codes are used to report treatment planning, dosimetry, treatment management, and other routine procedures.

Payment

Most procedures using the CyberKnife, TomoTherapy, and Radixact Systems are performed in the hospital outpatient department, where Medicare payment rates are established from hospital cost data. CMS pays separately for ancillary procedures in addition to radiation treatment delivery and SRS/SBRT, as well as through comprehensive ambulatory payment classifications that bundle delivery with certain ancillary services for single-session cranial radiosurgery. The revised delivery codes (77402, 77407, and 77412) are assigned to a corresponding three-tier structure of Ambulatory Payment Classifications under OPPS.

Payment for CyberKnife, TomoTherapy, and Radixact treatment is also available in the freestanding center setting. The robotic radiosurgery delivery codes (G0339 and G0340) remain contractor-priced by the regional Medicare Administrative Contractors for providers paid under the traditional fee-for-service methodology. For the revised radiation treatment delivery codes, CMS now uses the relationship between OPPS APC relative weights to inform freestanding (non-facility) practice expense valuation, aligning freestanding and hospital-based payment more closely than under the prior methodology. Rates continue to be adjusted geographically and are reviewed by CMS on an ongoing basis; healthcare reform proposals may further affect reimbursement for radiotherapy and radiosurgery. State Medicaid reimbursement is determined under each state’s Medicaid plan, subject to federal law and regulations.

Foreign Reimbursement

Internationally, reimbursement and healthcare payment systems vary significantly from country to country and include single payer, government managed systems as well as markets in which public and private payers operate side-by-side. In general, the process of obtaining coverage and establishing reimbursement approvals is complex, time-consuming, and often slower than in the United States, and may be subject to additional clinical and economic evidence requirements. Our ability to achieve adoption of our treatment systems, and significant sales volume in international markets, will depend in part on the availability of funding and reimbursement for procedures performed using our products.

Regulatory Matters

Domestic Regulation

Our products and software are medical devices subject to regulation by the FDA, as well as other regulatory bodies. FDA regulations govern the following activities that we perform and will continue to perform to ensure medical products distributed domestically or exported internationally are safe and effective for their intended uses:

Product design and development;

Document and purchasing controls;

Production and process controls;

Labeling and packaging controls;

Product storage;

Recordkeeping;

Servicing;

Corrective and preventive action and complaint handling;

Pre‑market clearance or approval;

Advertising and promotion; and

Product sales and distribution.

FDA pre-market clearance and approval requirements. Unless an exemption applies, each medical device we wish to commercially distribute in the United States will require either 510(k) clearance or pre‑market approval from the FDA. The FDA classifies medical devices into one of three classes (I, II, III). The FDA categorizes devices based on risk in either class I or II, depending upon the class, the manufacturer submits the applicable pre‑market notification to the FDA requesting permission to commercially distribute the device. For class II, the FDA requires 510(k) clearance before marketing and distribution. Some low risk devices are exempted from this requirement. Devices deemed by the FDA to pose the greatest risks, such as life‑sustaining, life‑supporting or implantable devices, or devices deemed not substantially equivalent to a previously cleared 510(k) devices, are placed in class III, requiring pre‑market approval. All of our current products are class II devices requiring 510(k) clearances.

510(k) clearance pathway. When a 510(k) clearance is required, we must submit a pre‑market notification demonstrating that our proposed device is substantially equivalent to a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of pre‑market approval (“PMA”) applications. By statute, the FDA has targets to clear or deny a 510(k) pre‑market notification after 90 days of FDA review time from submission of the application. Clearance generally takes longer as the FDA may require further information, including clinical data, that require our response and pauses the 90-day review time to make a determination regarding substantial equivalence.

In January 2002, we received 510(k) clearance for the TomoTherapy Hi Art System intended to be used as an integrated system for the planning and delivery of IMRT for the treatment of cancer. In August 2008, we received 510(k) clearance for our TomoDirect System. In June 2016, we introduced the Radixact Treatment Delivery Platform with 510(k) clearance. We expanded the Radixact Treatment Delivery Platform through subsequent 510(k) clearances to include Synchrony in November 2018 for real-time adaptive motion tracking and compensation, ClearRT in November 2020 for advanced imaging, and VitalHoldTM in August 2023 for Surface Guided Radiation Therapy (“SGRT”).

In July 1999, we received 510(k) clearance for the CyberKnife System for stereotactic radiosurgery and radiotherapy in the head and neck regions of the body. We received additional 510(k) clearances for CyberKnife System and options, including in April 2002 for the Synchrony Motion Tracking System as a real-time adaptive option, intended to enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under influence of respiration. We have grown our CyberKnife System with the July 2015 510(k) clearance of the M6 platform, including the InCise Multileaf Collimator and introducing the CyberKnife Treatment Delivery System to leverage our Accuray Precision Treatment Planning System in April 2017.

We introduced our new treatment planning and data management systems, Accuray Precision Treatment Planning System with iDMS Data Management System with 510(k) clearances in June 2016.

PMA pathway. A PMA must be submitted to the FDA if the device is not eligible for the 510(k) clearance process. A PMA must be supported by extensive data including, but not limited to, technical, preclinical, clinical trials, manufacturing and labeling to demonstrate reasonable evidence of the device’s safety and efficacy to the FDA’s satisfaction. Currently, no device we have developed and commercialized has required pre‑market approval.

Product modifications. After a device receives 510(k) clearance or a PMA approval, it may be changed or modified. Any modification that could significantly affect its safety or effectiveness, or that would constitute a significant change in its intended use, will require a new clearance or approval. Regulations provide that the manufacturer initially determines when a specific modification requires notification to FDA. The FDA has issued draft guidance that, if finalized and implemented, will result in manufacturers needing to seek a significant number of new clearances for changes made to legally marketed devices. The FDA reviews the manufacturer’s decision to file a 510(k) or PMA for modifications during facility audits.

We have modified aspects of our CyberKnife and TomoTherapy platforms since receiving initial regulatory clearance, and we have applied for and obtained additional 510(k) clearances for these modifications when we determined such clearances were required. The FDA may review our 510(k) filing decision, and can disagree with our initial determination. The FDA may take regulatory action from requiring new filings to injunction if it disagrees with our determinations not to seek a new 510(k) clearance or PMA approval for modifications.

Pervasive and continuing regulation. After a device is placed on the market, numerous regulatory requirements apply. These include:

Quality System Regulation (“QSR”), which require manufacturers, including third‑party manufacturers, to follow stringent design, testing, documentation and other quality assurance procedures during product design and throughout the manufacturing process;

Labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off‑label uses; and

Medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur.

The FDA has broad post‑market and regulatory enforcement powers, including cybersecurity as enhanced in March 2023 by the Food and Drug Omnibus Reform Act (“FDORA”). The latest FDA cybersecurity requirements apply to new devices at pre-market submission, such as 510(k) clearance. We are subject to unannounced inspections by the FDA and the Food and Drug Branch of the California Department of Health Services to determine our compliance with the QSR and other regulations, and these inspections may include the manufacturing facilities of some of our subcontractors. Our Madison facility, where we manufacture the finished TomoTherapy and CyberKnife Systems, was most recently inspected by the FDA in August 2017. The August 2017 inspection resulted in no observations. We voluntarily participate in the Medical Device Single Audit Program (“MDSAP”). The MDSAP program allows recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. The MDSAP participating members include FDA, Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency. FDA accepts MDSAP audit reports as a substitute for routine Agency inspections. We are routinely audited by an MDSAP-recognized Auditing Organization to international medical device requirements. We believe we are in substantial compliance with the QSR. Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:

Fines, injunctions, consent decrees and civil penalties;

Recall or seizure of our products;

Operating restrictions, partial suspension or total shutdown of production;

Refusing our requests for 510(k) clearance or pre‑market approval of new products or new intended uses;

Withdrawing 510(k) clearance or pre‑market approvals that are already granted; and

Criminal prosecution.

The FDA also has the authority to require us to repair, replace or refund the cost of any medical device that we have manufactured or distributed. If any of these events were to occur, they could have a material adverse effect on our business.

Radiological health. Because our CyberKnife and TomoTherapy platforms contain both laser and X‑ray components, and because we assemble these components during manufacturing and service activities, we are also regulated under the Electronic Product Radiation Control Provisions of the United States Federal Food, Drug, and Cosmetic Act. This law requires laser and X‑ray products to comply with regulations and applicable performance standards, and manufacturers of these products to certify in product labeling and reports to the FDA that their products comply with all such standards. The law also requires manufacturers to file new product reports, and to file annual reports and maintain manufacturing, testing and sales records, and report product defects. Various warning labels must be affixed. Assemblers of diagnostic X‑ray systems are also required to certify in reports to the FDA, equipment purchasers, and where applicable, to state agencies responsible for radiation protection, that diagnostic and/or therapeutic X‑ray systems they assemble meet applicable requirements. Failure to comply with these requirements could result in enforcement action by the FDA, which can include injunctions, civil penalties, and the issuance of warning letters.

Fraud and abuse laws. We are subject to various federal and state laws pertaining to healthcare fraud and abuse, including anti‑kickback laws and physician self‑referral laws. Violations of these laws are punishable by significant criminal and civil sanctions, including, in some instances, exclusion from participation in federal and state healthcare programs, including Medicare and Medicaid. Because of the far‑reaching nature of these laws, there can be no assurance that we would not be required to alter one or more of our practices to be in compliance with these laws. Evolving interpretations of current laws or the adoption of new federal or state laws or regulations could adversely affect many of the arrangements we have with customers and physicians. In addition, there can be no assurance that the occurrence of one or more violations of these laws or regulations would not result in a material adverse effect on our financial condition and results of operations.

Anti‑kickback laws. Our operations are subject to broad and changing federal and state anti‑kickback laws. The Office of the Inspector General of the Department of Health and Human Services (“OIG”) is primarily responsible for enforcing the federal Anti‑Kickback Statute and generally for identifying fraud and abuse activities affecting government programs. The federal Anti‑Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering or providing remuneration directly or indirectly to induce either the referral of an individual, or the furnishing, recommending, or arranging of a good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid. “Remuneration” has been broadly interpreted to include anything of value, including such items as gifts, discounts, the furnishing of supplies or equipment, credit arrangements, waiver of payments, and providing anything of value at less than fair market value.

Penalties for violating the federal Anti‑Kickback Statute include criminal fines of up to $25,000 and/or imprisonment for up to five years for each violation, civil monetary penalties, which could result in treble damages plus fines of up to $50,000 for each violation, and possible exclusion from participation in federal healthcare programs such as Medicare and Medicaid. Many states have adopted prohibitions similar to the federal Anti‑Kickback Statute, some of which apply to the referral of patients for healthcare services reimbursed by any source, not only by the Medicare and Medicaid programs, and do not include comparable exceptions.

The OIG has issued safe harbor regulations which set forth certain activities and business relationships that are deemed safe from prosecution under the federal Anti‑Kickback Statute. There are safe harbors for various types of arrangements, including, without limitation, certain investment interests, leases and personal services and management contracts. The failure of a particular activity to comply in all regards with the safe harbor regulations does not mean that the activity violates the federal Anti‑Kickback Statute or that prosecution will be pursued. However, conduct and business arrangements that do not fully satisfy each applicable safe harbor may result in increased scrutiny by government enforcement authorities such as the OIG.

The OIG has identified the following arrangements with purchasers and their agents as ones raising potential risk of violation of the federal Anti‑Kickback Statute:

Discount and free good arrangements that are not properly disclosed or accurately reported to federal healthcare programs;

Product support services, including billing assistance, reimbursement consultation and other services specifically tied to support of the purchased product, offered in tandem with another service or program (such as a reimbursement guarantee) that confers a benefit to the purchaser;

Educational grants conditioned in whole or in part on the purchase of equipment, or otherwise inappropriately influenced by sales and marketing considerations;

Research funding arrangements, particularly post‑marketing research activities, that are linked directly or indirectly to the purchase of products, or otherwise inappropriately influenced by sales and marketing considerations; and

Other offers of remuneration to purchasers that are expressly or impliedly related to a sale or sales volume, such as “rebates” and “upfront payments,” other free or reduced‑price goods or services, and payments to cover costs of “converting” from a competitor’s products, particularly where the selection criteria for such offers vary with the volume or value of business generated.

We have a variety of financial relationships with physicians who are in a position to generate business for us. For example, physicians who own our stock also provide medical advisory and other consulting or collaboration services. Similarly, we have a variety of different types of arrangements with our customers. In the case of our former placement program, certain services and upgrades were provided without additional charge based on procedure volume. In the past, we have also provided loans to our customers. We also provide research or educational grants to customers to support customer studies related to, among other things, our CyberKnife and TomoTherapy platforms.

If our past or present operations are found to be in violation of the federal Anti‑Kickback Statute or similar government regulations to which we or our customers are subject, we or our officers may be subject to the applicable penalty associated with the violation, including significant civil and criminal penalties, damages, fines, imprisonment, and exclusion from the Medicare and Medicaid programs. The impact of any such violation may lead to curtailment or restructuring of our operations. Any penalties, damages, fines, or curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results. The risk of our being found in violation of these laws is increased by the fact that some of these laws are open to a variety of interpretations. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our business and damage our reputation. If an enforcement action were to occur, our reputation and our business and financial condition could be harmed, even if we were to prevail or settle the action. Similarly, if the physicians or other providers or entities with which we do business are found to be non‑compliant with applicable laws, they may be subject to sanctions, which could also have a negative impact on our business.

Transparency laws. The Physician Payment Sunshine Act (the “Sunshine Act”), which was enacted by Congress as part of the Patient Protection and Affordable Care Act on December 14, 2011, requires each applicable manufacturer, which includes medical device companies, such as Accuray, to track and report to the federal government on an annual basis all payments and other transfers of value from such applicable manufacturer to U.S. licensed physicians and teaching hospitals as well as physician ownership of such applicable manufacturer’s equity, in each case subject to certain statutory exceptions. Such data will be made available by the government on a publicly searchable website. Failure to comply with the data collection and reporting obligations imposed by the Sunshine Act can result in civil monetary penalties ranging from $1,000 to $10,000 for each payment or other transfer of value that is not reported (up to a maximum of $150,000 per reporting period) and from $10,000 to $100,000 for each knowing failure to report (up to a maximum of $1 million per reporting period). In addition, we are subject to similar state and foreign laws related to the tracking and reporting of payments and other transfers of value to healthcare professionals. These laws require or will require that we implement the necessary and costly infrastructure to track and report such payments and transfers of value. Failure to comply with these new tracking and reporting laws could subject us to significant civil monetary penalties.

Physician self‑referral laws. We are also subject to federal and state physician self‑referral laws. The federal Ethics in Patient Referrals Act of 1989, commonly known as the Stark Law, prohibits, subject to certain exceptions, physician referrals of Medicare and Medicaid patients to an entity providing certain “designated health services” if the physician or an immediate family member has any financial relationship with the entity. The Stark Law also prohibits the entity receiving the referral from billing any good or service furnished pursuant to an unlawful referral.

In addition, in July 2008, CMS issued a final rule implementing significant amendments to the regulations under the Stark Law. The final rule, which was effective October 1, 2009, imposes additional limitations on the ability of physicians to refer patients to medical facilities in which the physician or an immediate family member has an ownership interest for treatment. Among other things, the rule provides that leases of equipment between physician owners that may refer patients and hospitals must be on a fixed rate, rather than a per use basis. Prior to enactment of the final rule, physician owned entities had increasingly become involved in the acquisition of medical technologies, including the CyberKnife platform. In many cases, these entities entered into arrangements with hospitals that billed Medicare for the furnishing of medical services, and the physician owners were among the physicians who referred patients to the entity for services. The rule limits these arrangements and could require the restructuring of existing arrangements between physicians owned entities and hospitals and could discourage physicians from participating in the acquisition and ownership of medical technologies. The final rule also prohibits percentage‑based compensation in equipment leases. As a result of the finalization of these regulations, some existing CyberKnife platform operators have modified or restructured their corporate or organizational structures. In addition, certain customers that planned to open CyberKnife centers in the United States involving physician ownership have restructured their legal ownership structure. Certain entities were not able to establish viable models for CyberKnife platform operation and therefore, canceled their CyberKnife platform purchase agreements. Accordingly, these regulations have resulted in cancellations of CyberKnife platform purchase agreements and could also reduce the attractiveness of medical technology acquisitions, including CyberKnife platform purchases, by physician owned joint ventures or similar entities. As a result, these regulations have had, and could continue to have, an adverse impact on our product sales and therefore, on our business and results of operations.

A person who engages in a scheme to circumvent the Stark Law’s referral prohibition may be fined up to $100,000 for each such arrangement or scheme. In addition, any person who presents or causes to be presented a claim to the Medicare or Medicaid programs in violations of the Stark Law is subject to civil monetary penalties of up to $15,000 per bill submission, an assessment of up to three times the amount claimed, and possible exclusion from federal healthcare programs such as Medicare and Medicaid. Various states have corollary laws to the Stark Law, including laws that require physicians to disclose any financial interest they may have with a healthcare provider to their patients when referring patients to that provider. Both the scope and exceptions for such laws vary from state to state.

Federal False Claims Act. The federal False Claims Act prohibits the knowing filing or causing the filing of a false claim or the knowing use of false statements to obtain payment from the federal government. When an entity is determined to have violated the False Claims Act, it may be required to pay three times the actual damages sustained by the government, plus mandatory civil penalties of between $14,308 and $28,619 for each separate false claim. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, sometimes known as “relators” or, more commonly, as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. In addition, certain states have enacted laws modeled after the federal False Claims Act. Qui tam actions have increased significantly in recent years, causing greater numbers of healthcare companies to have to defend a false claim action, pay fines or be excluded from Medicare, Medicaid or other federal or state healthcare programs as a result of an investigation arising out of such action. We have retained the services of a reimbursement consultant, for which we pay certain consulting fees, to provide us and facilities that have purchased a CyberKnife or TomoTherapy platform, with general reimbursement advice. While we believe this will assist our customers in filing proper claims for reimbursement, and even though such consultants do not submit claims on behalf of our customers, the fact that we provide these consultant services could expose us to additional scrutiny and possible liability in the event one of our customers is investigated and determined to be in violation of any of these laws.

HIPAA. The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), created two new federal crimes: healthcare fraud and false statements relating to healthcare matters. The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private payors. A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government sponsored programs. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. A violation of this statute is a felony and may result in fines or imprisonment.

As a participant in the healthcare industry, we are also subject to extensive federal and state laws and regulations protecting the privacy and integrity of patient medical information, including privacy and security standards required under HIPAA. The HIPAA privacy standard was amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), enacted as part of the American Recovery and Reinvestment Act of 2009. HITECH significantly increases the civil money penalties for violations of patient privacy rights protected under HIPAA. Although we are not a covered entity under HIPAA, we have entered into agreements with certain covered entities under which we are considered to be a “business associate” under HIPAA. As a business associate, we are required to implement policies, procedures and reasonable and appropriate security measures to protect individually identifiable health information we receive from covered entities. Furthermore, business associates are directly subject to regulations under HIPAA including the new enforcement scheme, criminal and civil penalties for certain violations, and inspection requirements.

Foreign Corrupt Practices Act. The United States and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry, including increased United States government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever the United States or another foreign governmental authority concludes that we are not in compliance with applicable laws or regulations, such governmental authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain or seize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees, and can recommend criminal prosecution to the Department of Justice. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of any device or product we manufacture or distribute. In addition, our third party agents in foreign countries can also subject us to prosecution under Foreign Corrupt Practices Act. We are also subject to the UK Bribery Act, which could also lead to the imposition of civil and criminal fines and other similar anti-bribery and anti-corruption laws. Any of the foregoing actions could result in decreased sales as a result of negative publicity and product liability claims, and could have a material adverse effect on our financial condition, results of operations and prospects.

International Regulation

International sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. The time required to obtain clearance or approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements are often different.

The primary regulatory environment in Europe is that of the European Union and the three additional member states of the European Economic Area (“EEA”), which have adopted similar laws and regulations with respect to medical devices. The European Union has adopted numerous regulations and directives and the European Committee for Standardization has promulgated standards regulating the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices. Devices that comply with the requirements of the relevant regulation or directive will be entitled to bear the Conformité Européene (“CE”) conformity marking, indicating that the device conforms to the essential requirements of the applicable directives and, accordingly, may be commercially distributed throughout the member states of the EEA.

The method of assessing conformity to applicable regulations, directives, and standards depends on the type and class of the product, but normally involves a combination of self‑assessment by the manufacturer and a third‑party assessment by a notified body, an independent and neutral institution appointed by a European Union member state to conduct the conformity assessment. This relevant assessment may consist of an audit of the manufacturer’s quality system (currently ISO 13485), provisions of the Medical Devices Regulation (“MDR”) and specific testing of the manufacturer’s device. Our facilities were first awarded the ISO 13485 certification in September 2002 and has been subsequently maintained through periodic assessments. The European Union MDR was published in May 2017 and came into effect in May 2021. We are currently authorized to affix the CE mark under the MDR to our products, allowing us to sell our products throughout the European Economic Area. We are required to obtain certification against the MDR to CE mark new products or to make significant changes to existing products. Under the MDR, our notified body may review the technical and clinical details of a product before permitting the CE mark for new products or significant changes. There are fewer notified bodies authorized under the MDR to qualify businesses and products. This may result in additional time for initial product reviews and to obtain authorization to apply the CE mark.

We are also currently subject to regulations in Japan. Under the Pharmaceutical Affairs Law in Japan, a pre‑market approval necessary to sell, market and import a product (Shonin) must be obtained from the Ministry of Health, Labor and Welfare (“MHLW”), for our products. A Japanese distributor received the first government approval to market the CyberKnife System from MHLW in November 1996. We received and maintain Shonin approval from MHLW for CyberKnife Treatment Delivery Systems, M6 Series with InCise MLC, TomoTherapy Treatment Delivery Systems, Radixact Treatment Delivery Systems, and associated Precision and iDMS software products.

Additionally, our products are subject to regulations in China. The China Supervision and Regulation of Medical Devices (No. 680) requires licensing from the NMPA to market, sell, and import our product type. Before application, the NMPA licenses require testing by a laboratory accredited in China, such as the Beijing Institute for Medical Devices Testing (“BIMT”) or Liaoning Medical Device Test Institute (“LMTI”). China has adopted international standards for safety and performance with national variations specific to China. We received and maintain NMPA licenses for various configurations of Radixact Treatment Delivery Systems, CyberKnife Treatment Delivery Systems, TomoTherapy Treatment Delivery Systems, and Precision (including iDMS) software products.

We are subject to additional regulations in other foreign countries, including, but not limited to, Canada, Taiwan, Korea, and Russia in order to sell our products. We expect that either we or our distributors will receive any necessary approvals or clearance prior to marketing or importing our products as required by international markets.

State Certificate of Need Laws

In some states, a certificate of need or similar regulatory approval is required prior to the acquisition of high‑cost capital items or the provision of new services. These laws generally require appropriate state agency determination of public need and approval prior to the acquisition of such capital items or addition of new services. Certificate of need regulations may preclude our customers from acquiring one of our systems, and from performing stereotactic radiosurgery procedures using one of our systems. Several of our prospective customers currently are involved in appeals of certificate of need determinations. If these appeals are not resolved in favor of these prospective customers, they may be precluded from purchasing and/or performing services using one of our systems. Certificate of need laws are the subject of continuing legislative activity, and a significant increase in the number of states regulating the acquisition and use of one of our systems through certificate of need or similar programs could adversely affect us.

Backlog

For a discussion of our fiscal 2026 backlog, please refer to the section entitled “Backlog,” in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Employees and Human Capital Resources

Our employees are critical to the success of our business. As of June 30, 2026, we had 809 employees, including 392 employees employed outside of the United States. We also engage part-time employees and independent contractors to supplement our workforce. None of our employees are represented by a labor union or covered by a collective bargaining agreement. We have never experienced any employment-related work stoppages, and we believe our relationship with our employees is good. We are dedicated to cultivating a diverse and inclusive work environment, essential for attracting and retaining exceptional talent. We believe that much of Accuray’s work can be done in a workplace which consists of a blend of flexible, digitally enabled remote work and purposeful in-person connection and collaboration; we have learned the importance of providing flexibility and wellbeing resources to our employees. Through ongoing employee development, comprehensive compensation and benefits, and other programs, we strive to help our employees in all aspects of their lives so they can do their best work.

Talent Development

We believe that investing in our employees’ development is essential for maintaining our competitive edge and fostering a culture of innovation and excellence. We offer various opportunities for our employees to enhance their skills, knowledge, and leadership abilities, such as online courses, mentoring programs, coaching sessions, and career development plans. We also conduct regular performance reviews and feedback surveys to assess our employees’ strengths, areas for improvement, and career aspirations. Our goal is to enable our employees to achieve their full potential and grow with the company.

Compensation & Benefits

The principal purposes of our compensation and incentive plans are to attract, retain, and reward personnel, in order to increase stockholder value and the success of our company by motivating our employees to perform to the best of their abilities and achieve our objectives. Accordingly, we seek to offer competitive compensation and benefits packages that align with our business objectives and reward our employees for their achievements. We also provide various incentives and recognition programs, such as equity awards, bonuses, service awards, and employee referral bonuses, to motivate and appreciate our employees. In addition to the comprehensive and competitive health plans that we offer, our employees receive access to the following benefits: a 401(k) retirement plan with a company match, an employee stock purchase plan, a company-provided basic life insurance and disability benefits, a corporate wellness program, an employee assistance program, and local employee discounts programs.

Geographic Information

For financial reporting purposes, net revenues and long‑lived assets attributable to significant geographic areas are presented in Note 14, Segment Disclosure, to the consolidated financial statements, which are incorporated herein by reference.

Available Information

Our main corporate website address is www.accuray.com. We make available on this website, free of charge, copies of our annual reports on Form 10‑K, quarterly reports on Form 10‑Q, current reports on Form 8‑K and our proxy statements, and any amendments to those reports, as soon as reasonably practicable after filing such material electronically or otherwise furnishing it to the Securities and Exchange Commission, the SEC. All SEC filings are also available at the SEC’s website at www.sec.gov.

We also use our investor relations website, as well as our corporate blog and social media channels, as channels of distribution for material company information in compliance with Regulation FD. For example, webcasts of our earnings calls and certain events we participate in or host with members of the investment community are on our investor relations website. Additionally, we announce investor information, including news and commentary about our business and financial performance, SEC filings, notices of investor events, and our press and earnings releases, on our investor relations website and through the social media channels identified on our investor relations website, including our accounts on X, LinkedIn, Facebook, Youtube and our corporate blog. The information we post through these channels may be deemed material. Investors and others can receive notifications of new information posted on our investor relations website in real time by signing up for email alerts and RSS feeds and can review and follow the social media channels listed on our investor relations website. Further corporate governance information, including our corporate governance guidelines, board committee charters, and code of conduct, is also available on our investor relations website under the heading “Governance.” The contents of our websites and social media channels are not incorporated by reference into this Annual Report on Form 10-K or in any other report or document we file with the SEC, and any references to our websites and social media channels are intended to be inactive textual references only.